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Medical Equipment Management
Healthcare Technology Management (also referred to as biomed, biomedical engineering,
bio-medical engineering, biomedical equipment management, biomedical equipment
services, biomedical maintenance, clinical engineering, clinical engineering management,
clinical equipment management, clinical technology management, clinical technology
services, medical equipment management, and medical equipment repair,) is a
fundamental part of managing and maintaining medical devices used or proposed for use
in various healthcare settings from the home, the field, the doctor's office, and the
hospital.
It includes the business processes used in
interaction and oversight of the medical
equipment involved in the diagnosis,
treatment, and monitoring of patients. The
related policies and procedures govern
activities such as the selection, planning, and
acquisition of medical devices. through to the
incoming inspection, acceptance,
maintenance, and eventual retirement and
disposal of medical equipment. Medical
equipment management is a recognized
profession within the medical logistics
domain. The healthcare technology
management professional's purpose is to
ensure that equipment and systems used in
patient care are operational, safe, and properly
configured to meet the mission of the healthcare; that the equipment is used in an
effective way consistent with the highest standards of care by educating the healthcare
provider, equipment user, and patient; that the equipment is designed to limit the
potential for loss, harm, or damage to the patient, provider, visitor, and facilities through
various means of analysis prior to and during acquisition, monitoring and foreseeing
problems during the lifecycle of the equipment, and collaborating with the parties who
manufacturer, design, regulate, or recommend safe medical devices and systems.
Some but not all of the healthcare technology management professional's functions are:
Equipment Control & Asset Management
Equipment Inventories
Work Order Management
Data Quality Management
Equipment Maintenance Management
Equipment Maintenance
Personnel Management
Quality Assurance
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Patient Safety
Risk Management
Hospital Safety Programs
Radiation Safety
Medical Gas Systems
In-Service Education & Training
Accident Investigation
Analysis of Failures, Root-Causes, and Human Factors
Safe Medical Devices Act (SMDA) of 1990
Health Insurance Portability and Accountability Act (HIPAA)
Careers in Facilities Management
Equipment Control & Asset Management
Every medical treatment facility should have policies and processes on equipment control
& asset management. Equipment control and asset management involves the
management of medical devices within a facility and may be supported by automated
information systems (enterprise resource planning systems from Lawson Software are
often found in U.S. hospitals, and the U.S. military health system uses an advanced
automated system known as the Defense Medical Logistics Standard Support (DMLSS)
suite of applications. Equipment control begins with the receipt of a newly-acquired
equipment item and continues through the item's entire life-cycle. Newly-acquired
devices should be inspected by in-house or contracted biomedical equipment technicians
(BMETs), who will establish an equipment control / asset number against which
maintenance actions are recorded. This is similar to creating a new chart for a new patient
that will be seen at the medical facility. Once an equipment control number is established,
the device is safety inspected and readied for delivery to clinical and treatment areas in
the facility.
Facilities or healthcare delivery networks may rely on a combination of equipment
service providers such as manufacturers, third party services, in-house technicians, and
remote support. Equipment managers are responsible for continuous oversight and
responsibility for ensuring safe and effective equipment performance through full service
maintenance. Medical equipment managers are also responsible for technology
assessment, planning and management in all areas within a medical treatment facility
(e.g. developing policies and procedures for the medical equipment management plan,
identifying trends and the need for staff education, resolution of defective biomedical
equipment issues).
This industry is new, and there is not a clear line between IT and Bio med.
Work Order Management
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Work order management involves systematic, measurable, and traceable methods to all
acceptance/initial inspections, preventive maintenance, and calibrations, or repairs by
generating scheduled and unscheduled work orders. Work order management may be
paper-based or computer-base and includes the maintenance of active (open or
uncompleted) and completed work orders which provide a comprehensive maintenance
history of all medical equipment devices used in the diagnosis, treatment, and
management of patients. Work order management includes all safety, preventive,
calibration, test, and repair services performed on all such medical devices. A
comprehensive work order management system can also be used as a resource and
workload management tool by managers responsible for personnel time, total number of
hour’s technician spent working on equipment, maximum repair dollar for one time
repair, or total dollar allowed to spend repairing equipment versus replacement. Postwork order quality checks involve one of two methods: 100% audit of all work orders or
statistical sampling of randomly-selected work orders. Randomly-selected work orders
should place more stringent statistical controls based on the clinical criticality of the
device involved. For example, 100% of items critical to patient treatment but only 50% of
ancillary items may be selected for sampling. In an ideal setting, all work orders are
checked, but available resources may dictate a less comprehensive approach. Work
orders must be tracked regularly and all discrepancies must be corrected.
Data Quality Management
Accurate, comprehensive data is needed in any automated medical equipment
management system. Data quality initiatives can help to insure the accuracy of
clinical/biomedical engineering data. The data needed to establish basic, accurate,
maintainable automated records for medical equipment management includes:
nomenclature, manufacturer, nameplate model, serial number, acquisition cost, condition
code, and maintenance assessment. Other useful data could include: warranty, location,
other contractor agencies, scheduled maintenance due dates, and intervals. These fields
are vital to ensure appropriate maintenance is performed, equipment is accounted for, and
devices are safe for use in patient care.
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Nomenclature: It defines what the device is, how, and the type of maintenance is
to be performed. Common nomenclature systems are taken directly from the
Emergency Care Research Institute (ECRI) Universal Medical Device
Nomenclature System.
Manufacturer: This is the name of the company that received approval from the
FDA to sell the device, also known as the Original Equipment Manufacturer
(OEM).
Nameplate model: The model number is typically located on the front/behind of
the equipment or on the cover of the service manual and is provided by the OEM.
E.g. Medtronic PhysioControl’s Lifepak 10 Defibrillator can actually be anyone
of the following correct model numbers listed: 10-41, 10-43, 10 -47, 10-51, and
10-57.
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Serial number: This is usually found on the data plate as well, is a serialized
number (could contain alpha characters) provided by the manufacturer. This
number is crucial to device alerts and recalls.
Acquisition cost: The total purchase price for an individual item or system. This
cost should include installation, shipping, and other associated costs. These
numbers are crucial for budgeting, maintenance expenditures, and depreciation
reporting.
Condition code: This code is mainly used when an item is turned in and should be
changed when there are major changes to the device that could affect whether or
not an item should be salvaged, destroyed, or used by another Medical Treatment
Facility.
Maintenance assessment: This assessment must be validated every time a BMET
performs any kind of maintenance on a device.
Several other management tools, such as equipment replacement planning and budgeting,
depreciation calculations, and at the local level literature, repair parts, and supplies are
directly related to one or more of these fundamental basics. Data Quality must be tracked
monthly and all discrepancies must be corrected.
Personnel Management
This area is crucial to the daily work activities. Biomedical managers must be able to
correctly assign staff for the right job. Having a team leader/veteran is important for
mentoring staff that might not have as much experience. The monthly timesheet provides
a method to record the time each person was available for work during the month. The
timesheet provides a gross breakout of how the time
was spent, and provides a basis for productivity
analysis reports. It also provides the monthly manhour accounting data. This data can be used to
process performance information about individual
staff/team members. Each staff member should
provide the following values of time, rounded to the
nearest tenth of an hour, for monthly processing:
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Regular hours
Overtime hours
Non-duty absence
Duty absence
Administrative support hours
Technician training hours
Supervisory hours
Travel hours
The following examples are calculations you can use for personnel management:
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Total hours = Regular hours + Overtime hours
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Hours available for work = Total hours - (Non-duty absence and Duty absence)
Hours available for maintenance = Hours available for work - (Administrative
support hours, Technical training hours, Supervisory hours, and Travel hours)
Quality Assurance
Quality Assurance is a way of identifying an item of supply or equipment as being
defective. A good quality control/engineering program improves quality of work and
lessens the risk of staff/patient injuries/death.
Patient Safety
Safety of our patients/staff is paramount to the success of our organizations mission. The
Joint Commission on the Accreditation of Healthcare Organizations publishes annual lists
detailing “National Patient Safety Goals” to be implemented by healthcare organizations.
Goals are developed by experts in patient safety nurses, physicians, pharmacists, risk
managers, and other professionals with patient-safety experience in a variety of settings.
Patient safety is among the most important goals of every healthcare provider, and
participation in a variety of committees and processes concerned with patient safety
provides a way for biomedical managers and clinical engineering departments to gain
visibility and positively affect their workplace.
Risk management
This program helps the medical treatment facility avoid the likelihood of equipmentrelated risks, minimize liability of mishaps and incidents, and stay compliant with
regulatory reporting requirements. The best practice is to use a rating system for every
equipment type. For example, a risk-rating system might rate defibrillators as considered
high risk, general-purpose infusion pumps as medium risk, electronic thermometers as
low risk, and otoscopes as no significant risk. This system could be set up using
Microsoft Excel or Access program for a manager's or technician's quick reference.
In addition, user error, equipment abuse, no problem/fault found occurrences must be
tracked to assist risk management personnel in determining whether additional clinical
staff training must be performed.
Risk management for IT networks incorporating medical devices will be covered by the
standard ISO/IEC 80001. Its purpose is: "Recognizing that MEDICAL DEVICES are
incorporated into IT-NETWORKS to achieve desirable benefits (for example,
INTEROPERABILITY), this international standard defines the roles, responsibilities and
activities that are necessary for RISK MANAGEMENT of IT-NETWORKS
incorporating MEDICAL DEVICES to address the KEY PROPERTIES". It resorts some
basic ideas of ISO 20000 in the context of medical applications, e.g. configuration,
incident, problem, change and release management, and risk analysis, control and
evaluation according to ISO 14971. IEC 80001 "applies to RESPONSIBLE
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ORGANIZATIONS, MEDICAL DEVICE manufacturers and other providers of
information technologies for the purpose of comprehensive RISK MANAGEMENT".
Hospital Safety Programs
The Joint Commission stipulates seven management plans for hospital accreditation. One
of the seven is safety. Safety includes a range of hazards including mishaps, injuries on
the job, and patient care hazards. The most common safety mishaps are "needle-sticks"
(staff accidentally stick themselves with a needle) or patient injury during care. As a
manager, ensure all staff and patients are safe within the facility. Note: it’s everyone’s
responsibility!
There are several meetings that medical equipment managers are required to attend as the
organizations technical representative. The following are:
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Patient Safety
Environment of Care
Space Utilization Committee
Equipment Review Board
Infection Control (optional)
Educational Requirements For Bio-Medical Engineer : Students should take the most
challenging science, math, and English courses available in high school. All biomedical
engineers have at least a bachelor's degree in engineering. Many have advanced graduate
degrees as well. Courses of study include a sound background in mechanical, chemical,
or industrial engineering, and specialized biomedical training. Most programs last from
four to six years, and all states require biomedical engineers to pass examinations and be
licensed.
Duties & Responsibilities For the Bio-Medical
Engineer:
Description: Biomedical Engineers use engineering principles to solve health related and
medical problems. They do a lot of research in conjunction with life scientists, chemists,
and medical professionals to design medical devices like artificial hearts, pacemakers,
dialysis machines, and surgical lasers. Some conduct research on biological and other life
systems or investigate ways to modernize laboratory and clinical procedures. Frequently,
biomedical engineers supervise biomedical equipment maintenance technicians,
investigate medical equipment failure, and advise hospitals about purchasing and
installing new equipment. Biomedical engineers work in hospitals, universities, industry,
and research laboratories.
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Working Conditions: Biomedical engineers work in offices, laboratories, workshops,
manufacturing plants, clinics and hospitals. Some local travel may be required if medical
equipment is located in various clinics or hospitals. Most biomedical engineers work
standard weekday hours. Longer hours may be required to meet research deadlines, work
with patients at times convenient to them, or work on medical equipment that is in use
during daytime hours.
Duties:
Biomedical engineers work closely with life scientists, chemists and medical
professionals (physicians, nurses, therapists and technicians) on the engineering aspects
of biological systems. Duties and responsibilities vary from one position to another but,
in general, biomedical engineers:
• design and develop medical devices such as artificial hearts and kidneys, pacemakers,
artificial hips, surgical lasers, automated patient monitors and blood chemistry sensors.
• design and develop engineered therapies (for example, neural-integrative prostheses).
• adapt computer hardware or software for medical science or health care applications
(for example, develop expert systems that assist in diagnosing diseases, medical imaging
systems, models of different aspects of human physiology or medical data management).
• conduct research to test and modify known theories and develop new theories.
• ensure the safety of equipment used for diagnosis, treatment and monitoring.
• investigate medical equipment failures and provide advice about the purchase and
installation of new equipment.
• develop and evaluate quantitative models of biological processes and systems.
• apply engineering methods to answer basic questions about how the body works.
• contribute to patient assessments.
• prepare and present reports for health professionals and the public.
• supervise and train technologists and technicians.
Biomedical engineers may work primarily in one or a combination of the following
fields: Italic text • bioinformatics – developing and using computer tools to collect and
analyze data.
• bioinstrumentation – applying electronic and measurement techniques.
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• biomaterials – developing durable materials that are compatible with a biological
environment.
• biomechanics - applying knowledge of mechanics to biological or medical problems.
• bio-nano-engineering – developing novel structures of nanometer dimensions for
application to biology, drug delivery, molecular diagnostics, microsystems and
nanosystems.
• biophotonics – applying and manipulating light, usually laser light, for sensing or
imaging properties of biological tissue.
• cellular and tissue engineering – studying the anatomy, biochemistry and mechanics
of cellular and sub-cellular structures, developing technology to repair, replace or
regenerate living tissues and developing methods for controlling cell and tissue growth in
the laboratory.
• clinical engineering – applying the latest technology to health care and health care
systems in hospitals.
• genomics and genetic engineering – mapping, sequencing and analyzing genomes
(DNA), and applying molecular biology methods to manipulate the genetic material of
cells, viruses and organisms.
• medical or biological imaging – combining knowledge of a physical phenomenon (for
example, sound, radiation or magnetism) with electronic processing, analysis and display.
• molecular bioengineering – designing molecules for biomedical purposes and
applying computational methods for simulating biomolecular interactions.
• systems physiology - studying how systems function in living organisms.
• therapeutic engineering – developing and discovering drugs and advanced materials
and techniques for delivering drugs to local tissues with minimized side effects.
References
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Bowles, Roger "Techcareers: Biomedical Equipment Technicians" TSTC
Publishing
Dyro, Joseph., Clinical Engineering Handbook (Biomedical Engineering).
Khandpur, R. S. "Biomedical Instrumentation: Technology and Applications".
McGraw Hills
Northrop, Robert B., "Noninvasive Instrumentation and Measurement in Medical
Diagnosis (Biomedical Engineering)".
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Webb, Andrew G., "Introduction to Biomedical Imaging (IEEE Press Series on
Biomedical Engineering)".
Yadin David, Wolf W. von Maltzahn, Michael R. Neuman, and Joseph D.
Bronzino,. Clinical Engineering (Principles and Applications in Engineering).
Villafañe, Carlos CBET: "Biomed: From the Student's Perspective" (ISBN # 9781-61539-663-4). www.Biomedtechnicians.com.